To evaluate an outbreak of fever and hypotension after cardiac surgical procedures and the role of polygeline, a plasma expander.
Unmatched case-control study.
A six-bed cardiac surgery intensive care unit (SICU) of the Hospital Clinic of Barcelona (Spain), a 940-bed public teaching hospital.
Eight cases and 25 control patients admitted to the SICU over a 4-week epidemic period.
Development of hypotension (systolic blood pressure ≤ 90 mm Hg or a drop of 40 mm Hg from baseline systolic blood pressure) and fever (axillary temperature >38.5°C) within 24 hours of a cardiac surgical procedure.
The single risk factor significantly different between cases and controls was the total volume of polygeline used throughout the surgical procedure for extracorporeal circulation: a median of 1,250 mL (mean, 1,312.5 ± 842.5 mL) in cases versus 500 mL (mean, 566.0 ± 159.9 mL) in controls (P = .0029). By multiple logistic regression analysis, polygeline use was the single risk factor significantly related to the outcome (odds ratio, 8.75; CI95, 1.36 to 56.2; P= .01). Neither blood cultures from patients nor cultures of the polygeline used yielded growth of any microorganism. Stopping use of the implicated polygeline lot controlled the outbreak.
Use of polygeline was associated with an outbreak of fever and hypotension in a SICU. Information from the manufacturer indicated the likelihood of contamination of the product with Bacillus stearothermophilus components. The manufacturer has since changed the production and control processes, and no further adverse events have been seen.